Patient Information
SINGULAIR (SING-u-lair)Tablets, ChewableTablets, and Oral Granules
Generic name: montelukast (mon-te-LOO-kast) sodium
9628414
Kttdd this IllfoiUldtlUl) before you stdlt tdkiny
SINGULAIR
AI30, read the leaflet you get each time
you refill SINGULAIR, since there may be new information
in the leaflet
3
ince the lost time you sow it This leaflet
does not take the place of talking with your doctor
about your medical condition and/or your treatment.
What is SINGULAIR*?
• SINGULAIR is a medicine called a leukotriene
receptor antagonist. It works by blocking
substances in the body called leukotrienes.
Blocking leukotrienes improves asthma and allergic
rhinitis. SINGULAIR is not a steroid. Studies have
shown that SINGULAIR does not affect the growth
rote of children. (See the end of this leaflet for more
information about asthma and allergic rhinitis.)
SINGULAIR is prescribed for the treatment of asthma,
the prevention of exercise-induced asthma, and
allergic rhinitis:
1
. Asthma.
SINGULAIR should be used for the long-term
management of asthma in adults and children
ages
12
months and older.
Do nottake SINGULAIR forthe immediate relief
of an asthma attack. If you get an asthma attack,
you should follow the instructions your doctor
gave you for treating asthma attacks.
2
. Prevention of exercise-induced asthma.
SINGULAIR is used for the prevention of exercise-
induced asthma in patients
15
years of age and older.
3
. Allergic Rhinitis.
SINGULAIR is used to help control the symptoms
of allergic rhinitis (sneezing, stuffy nose, runny
nose, itching of the nose). SINGULAIR is used to
treat seasonal allergic rhinitis (outdoor allergies
that happen part of the year) in adults and children
ages
2
years and older, and perennial allergic
rhinitis (indoor allergies that happen all year) in
adults and children ages
6
months and older.
Who should not take SINGULAIR?
Do not take SINGULAIR if you are allergic to SINGULAIR
or any of its ingredients.
The active ingredient in SINGULAIR is montelukast
sodium.
See the end of this leaflet for a list of all the ingredients
in SINGULAIR.
What should I tell my doctor before I start taking
SINGULAIR?
Tell your doctor about:
• Pregnancy: If you are pregnant or plan to become
pregnant, SINGULAIR may not be right for you.
• Breast-feeding: If you are breast-feeding,
SINGULAIR may be passed in your milk to your
baby. You should consult your doctor before
taking SINGULAIR if you are breast-feeding or
intend to breast-feed.
• Medical Problems or Allergies: Talk about any
medical problems or allergies you have now or
had in the past.
• Other Medicines: Tell your doctor about all
the medicines you take, including prescription
and non-prescription medicines, and herbal
supplements. Some medicines may affect how
SINGULAIR works, or SINGULAIR may affect
how your other medicines work.
How should I take SINGULAIR?
For adults and children
12
months of age and older
w ith asthma:
• Take SINGULAIR once a day in the evening.
• Take SINGULAIR every day for as long as your
ductui piesciibes it, even if you have no asthma
symptoms.
• You may take SINGULAIR with food oi without food.
• If your asthma symptoms get worse, or if you
need to increase the use of your inhaled rescue
medicine for asthma attacks, call your doctor
right away.
• Do not take SINGULAIR forthe immediate relief
of an asthma attack. If you get an asthma attack,
you should follow the instructions your doctor
gave you for treating asthma attacks.
• Always have your inhaled rescue medicine for
asthma attacks with you.
• Do not stop taking or lower the dose of your other
asthma medicines unless your doctor tells you to.
For patients
15
years of age and older for the
prevention of exercise-induced asthma:
• Take SINGUl AIR at least
2
hours before exercise.
• Always have your inhaled rescue medicine for
asthma attacks with you.
• If you are taking SINGULAIR daily for chronic
asthma or allergic rhinitis, do nol lake an
additional dose to prevent exercise-induced
asthma. Spuak to your doctor about your
* Registered trademark of MERCK A CO.
. Inc.
COPYRIGHI £' 1998-200/ M tKC K & L’U.
. Inc.
All rights reserved
tre a tm e n t ol e xe icise -m d u ce d asthm a.
• Do not take an additional dose of SINGULAIR
within
24
hours of a previous dose.
Tor a d u lts and c h ild re n 2 years o f age and o ld e r
w ith seasonal a lle rg ic rh in itis , or fo r a d u lts and
c h ild re n 6 m o n th s o f age and o ld e r w ith p e re n n ia l
a lle rg ic rh in itis ;
• Take SINGULAIR once a day, at aboutthe same
time each day.
• Take SINGULAIR every day for as long as your
doctor prescribes it.
• You
m ay take
SINGULAIR with food or without food.
H ow should I give SINGULAIR oral granules to m y child?
Do not open the packet until ready to use.
SINGULAIR
4
-mg oral granules can be given:
• directly in the mouth;
• dissolved in
1
teaspoonful
(5
mL) of cold or room
tomporature baby formula or broast milk;
• mixed with a spoonful of one of the following soft
foods at cold or room temperature: applesauce,
mashed carrots, rice, or ice cream.
Be sure that the entire dose is mixed with the food,
baby formula, or breast milk and that the child is
given the entire spoonful of the food, baby formula, or
breast milk mixture right away (within
15
minutes).
IMPORTANT: N ever sto re any oral g ra n u le s m ixed
w ith fo o d , baby fo rm u la , o r b re a st m ilk fo r use a t a
la te r tim e . T h ro w aw ay any unused p o rtio n .
Do n o t p u t S IN G U LAIR o ra l g ra n u le s in any
liq u id d rin k o th e r th a n baby fo rm u la or b reast
m ilk .
However, your child may drink liquids after
swallowing the SINGULAIR oral granules.
W h a t is th e dose o f SING ULAIR?
For a s th m a —Take once d a ily in th e evening:
• One
10
-mg tablet for adults and adolescents
15
years of age and older,
• One
5
-mg chewable tablet for children 6 to
14
years of age,
• One
4
-mg chewable tablet or one packet of
4
-mg
oral granules for children
2
to
5
years of age, or
• One packet of
4
-mg oral granules for children
12
to
23
months of age.
For e xe rcise -in d u ce d a s th m a —Take a t le a st 2 hours
be fo re exercise, b u t n o t m o re th a n once d a ily :
• One
10
-mg tablet for adults and adolescents
15
years of age and older
For a lle rg ic rh in itis -T a k e once d a ily a t a b o u t th e
sam e tim e each day:
• One
10
-mg tablet for adults and adolescents
15
years of age and older,
• One
5
-mg chewable tablet for children 6 to
14
years of age,
• One
4
-mg chewable tablet for children
2
to
5
years of age, or
• One packet of
4
-mg oral granules for children
2
to
5
years of age with seasonal allergic rhinitis,
or for childron 6 months to
5
yoars of age with
perennial allergic rhinitis.
W h a t s h o u ld I avoid w h ile ta k in g SIN G U LAIR?
If you have asthma and if your asthma is made
worse by aspirin, continue to avoid aspirin or other
medicines called non-steroidal anti-inflammatory
drugs while taking SINGULAIR.
W h a t are th e p o ssib le side e ffe c ts o f SING ULAIR?
The side effects of SINGULAIR are usually mild, and
generally did not cause patients to stop taking their
medicine. The side effects in patients treated with
SINGULAIR were similar in type and frequency to side
effects in patients who were given a placebo (a pill
containing no medicine).
The most common side effects with SINGULAIR
include:
• stomach pain
• sto m a ch or in te s tin a l upset
• heartburn
•
tiredness
• fever
• s tu ffy nose
• cough
• flu
• upper respiratory infection
• dizziness
• headache
• rash
Less common side effects that have happened with
SINGULAIR include.
• increased bleeding tendency
• allei gic i sections (including swelling of the face, lips,
tongue, and/or throat (which may cause trouble
breathing or swallowing), hives and itching]
• behavior and mood related changes (agitation
including aggressive behavior, bad/vivid dreams,
depression, feeling anxious, hallucinations
(seeing things that are not there), irritability,
restlessness, suicidal thoughts and actions
(including suicide), tremor, trouble sleeping]
• d ro w sin e ss, p in s and n e edles/num bness.
s e iz u re s (c o n v u ls io n s u i Ids)
• palpitations
• nosebleed
• diarrhea, indigestion, inflammation of the
pancreas, nausea, vomiting
• hepatitis
• bruising
• joint pain, muscle aches and muscle cramps
• swelling
Rarely, asthmatic patients taking SINGULAIR have
experienced a condition that includes certain
symptoms that do not go away or that get worse.
These occur usually, but not always, in patients who
were taking steroid pills by mouth for asthma and
those steroids were being slowly lowered or stopped.
Although SINGULAIR has not been shown to cause
this condition, you must tell your doctor right away if
you get one or more of these symptoms:
• a feeling of pins and needles or numbness of
arms or logs
• a flu-like illness
• rash
• severe inflammation (pain and swelling) of the
sinuses (sinusitis)
These are not all the possible side effects of SINGULAIR.
For more information ask your doctor or pharmacist.
Talk to your doctor if you think you have side effects
from taking SINGULAIR.
General Information about the safe and effective use
of SINGULAIR
Medicines are sometimes prescribed for conditions
that arc not mentioned in patient information leaflets.
Do not use SINGULAIR for a condition for which it
was not prescribed. Do not give SINGULAIR to other
people even if they have the same symptoms you
have. It may harm them. Keep SINGULAIR and all
medicines out of the reach of children.
Store SINGULAIR at
25
°C <
77
*F). Protect from moisture
and light. Store in original package.
This leaflet summarizes information about
SINGULAIR. If you would like more information, talk
to your doctor. You can ask your pharmacist or doctor
for information about SINGULAIR that is written for
health professionals.
What are the ingredients in SINGULAIR?
Active ingredient: montelukast sodium
SINGULAIR chewable tablets contain aspartame,
a source of phenylalanine.
Phcnylkotonurics: SINGULAIR
4
mg and
5
mg
chewable tablets contain
0.674
and
0.842
mg
phenylalanine, respectively.
Inactive ingredients:
•
4
-mp oral granules: mannitol, hydroxypropyl
cellulose, and magnesium stearate.
•
4
-mn and
5
-mn chewable tablets: mannitol,
microcrystalline cellulose, hydroxypropyl
cellulose, red ferric oxide, croscarmollosc
sodium, cherry flavor, aspartame, and
magnesium stearate.
•
10-mg tablet: microcrystalline cellulose, lactose
monohydrate, croscarmellose sodium, hydroxypropyl
cellulose, magnesium stearate, hydroxypropyl
methylcellulose, titanium dioxide, red ferric
oxide, yellow ferric oxide, and carnauba wax.
What is asthma?
Asthma is a continuing (chronic) inflammation of the
bronchial passageways which are the tubes that carry
air from outside the body to the lungs.
Symptoms of asthma include:
• coughing
• wheezing
• chest tightness
• sh o rtn e ss o f breath
W h a t is e xe rcise -in d u ce d a&thm a?
Cxercise-induced asthma, more accurately called
exercise-induced bronchoconstriction occurs when
exercise triggers symptoms of asthma.
What is allergic rhinitis?
• Seasonal allergic rhinitis, also known as hay fever,
is triggered by outdoor allergens such as pollens
from trees, arasses, and weeds.
• Perennial allergic rhinitis may occur year-round and
is generally triggered by indoor allergens such as
dust mites, animal dander, and/or mold spores.
• Symptoms of allergic rhinitis may include:
• stuffy, runny, and/or itchy nose
• sneezing
Rxonly
US Patent No.:
5
.
565,473
Issued July
2008
Distributed by:
MFRCK
&
CO., INC.
Whitehouse Station. NJ
00009
, USA
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085
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6
)(
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